Permethrin

ELIMITE™ 5% Cream is available as follows:

60 g tube (NDC 40076-115-60)

Storage

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

Manufactured for Prestium Pharma, Inc., Newtown, PA 18940. by Perrigo Pharmaceuticals, Allegan, MI 49010. Rev. Aug 2015

This is not a complete list of Permethrindrug interactions. Ask your doctor or pharmacist for more information.

Storage

Topical

15–25°C.2 13 90 Viscosity decreases at higher temperatures and product separation may occur.69 2 13

15–25°C89 or 20–25°C,1 depending on the manufacturer.

Permethrin, a pyrethroid, is active against a broad range of pests including lice, ticks, fleas, mites, and other arthropods. It acts on the nerve cell membrane to disrupt the sodium channel current by which the polarization of the membrane is regulated. Delayed repolarization and paralysis of the pests are the consequences of this disturbance.

Permethrin is rapidly metabolized by ester hydrolysis to inactive metabolites which are excreted primarily in the urine. Although the amount of Permethrin absorbed after a single application of the 5% cream has not been determined precisely, data from studies with 14C-labeled Permethrin and absorption studies of the cream applied to patients with moderate to severe scabies indicate it is 2% or less of the amount applied.

General -

Scabies infestation is often accompanied by pruritus, edema, and erythema. Treatment with Permethrin Cream, 5% may temporarily exacerbate these conditions.

Information for Patients -

Patients with scabies should be advised that itching, mild burning and/or stinging may occur after application of Permethrin Cream, 5%. In clinical trials, approximately 75% of patients treated with Permethrin cream, 5% who continued to manifest pruritus at 2 weeks had cessation by 4 weeks. If irritation persists, they should consult their physician. Permethrin Cream, 5% may be very mildly irritating to the eyes. Patients should be advised to avoid contact with eyes during application and to flush with water immediately if Permethrin Cream, 5% gets in the eyes.

Carcinogenesis, Mutagenesis, Impairment of Fertility -

Six carcinogenicity bioassays were evaluated with Permethrin, three each in rats and mice. No tumorigenicity was seen in the rat studies. However, species-specific increases in pulmonary adenomas, a common benign tumor of mice of high spontaneous background incidence, were seen in the three mouse studies. In one of these studies there was an increased incidence of pulmonary alveolar-cell carcinomas and benign liver adenomas only in female mice when Permethrin was given in their food at a concentration of 5000 ppm. Mutagenicity assays, which give useful correlative data for interpreting results from carcinogenicity bioassays in rodents, were negative. Permethrin showed no evidence of mutagenic potential in a battery of in vitro and in vivo genetic toxicity studies.

Permethrin did not have any adverse effect on reproductive function at a dose of 180 mg/kg/day orally in a three-generation rat study.

Pregnancy: Teratogenic Effects: Pregnancy Category B -

Reproduction studies have been performed in mice, rats, and rabbits (200 to 400 mg/kg/day orally) and have revealed no evidence of impaired fertility or harm to the fetus due to Permethrin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers -

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the evidence for tumorigenic potential of Permethrin in animal studies, consideration should be given to discontinuing nursing temporarily or withholding the drug while the mother is nursing.

Pediatric Use -

Permethrin Cream, 5% is safe and effective in pediatric patients two months of age and older. Safety and effectiveness in infants less than two months of age have not been established.

Geriatric Use -

Clinical studies of Permethrin cream, 5% did not identify sufficient numbers of subjects aged 65 and over to allow a definitive statement regarding whether elderly subjects respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. This drug is known to be substantially excreted by the kidney. However, since topical Permethrin is metabolized in the liver and excreted in the urine as inactive metabolites, there does not appear to be an increased risk of toxic reactions in patients with impaired renal function when used as labeled.

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

Manufactured by Perrigo

Bronx, NY 10457

Distributed By

Perrigo®

Allegan, MI 49010 • www.perrigo.com

Rev 08-15

: 1T600 RC JX1

(per METH rin)

Head lice (lotion/cream rinse): Treatment of head lice (Pediculus humanus capitis) and its nits (eggs).

Scabies (cream): Treatment of scabies (Sarcoptes scabiei) infestation.

There are no known significant interactions.

Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Consult your pharmacist.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.